国际多中心药物临床试验伦理审查的困境与对策研究

The Dilemma and Countermeasures in Ethical Review of International Multi- center Clinical Trials

随着医药技术的不断发展和国际合作的日渐加深,国际多中心药物临床试验也越来越多,我们有必要对多中心伦理审查中出现的问题进行思考,这主要包括试验参与各方利益的博弈;多中心国家之间的伦理标准冲突;多中心伦理审查质量存在差异;药物试验方法与伦理原则的矛盾等方面。面对如此困境,需要提高各中心伦理委员会成员的素质和能力,加强各中心之间的有效沟通,注重协调各中心之间的利益,处理好临床试验方法与伦理要求的关系。

As medical technology continues to evolve, deepening international cooperation, international multi-center clinical trials are also more and more, we need to review the multi-center ethical issues that arise for reflection, which is mainly the interests of the parties involved, including test game; conflicts between ethical standards in multi-center nations; ethical review of multi-center quality differences; drug testing methods and other aspects of the contradictions of ethical principles. Faced with this dilemma, we should improve the quality of the ethics committee of the centers and the ability to enhance effective communication between the centers, focusing on coordination of central interest, and coordinate the requirements of clinical trial methodology and ethical relationships.